COVID 19 Pneumonia
Conditions
Brief summary
Methods: Single-center pilot study included PCR+ SARS-CoV2-patients, hospitalized from April to May 2020 in Puebla, Mexico. Comparative treatment with steroids plus CsA or steroids. Mild, moderate or severe pneumonia was measured by clinical, laboratory tests, lung damage score by computed tomography, and score for clinical improvement. Death rate was evaluated at 28 days.
Detailed description
This is a pilot study done in a single center (ISSSTE Regional Hospital, Puebla, Mexico). Consecutive patients with suspected or confirmed diagnosis of COVID-19 were assigned, in an unblinded and non-randomized fashion, to receive either steroids plus CsA (intervention group) or steroids only (standard of treatment in this hospital, control group), as per individual clinical judgment. The primary outcome was the number of days to clinical improvement until hospital discharge or death. The secondary outcome was the improvement of patients, defined by the following parameters: lower oxygen requirements (2 liters per minute, or less), absence of fever by three consecutive days, respiratory rate \<22, a decrease of 50% or more in the C reactive protein on admission, and length of hospital stay. Adult patients attending to the hospital between April 15, to May 31, 2020, fulfilling symptoms compatible with COVID-19 pneumonia, according to the WHO guidance, were invited to participate and all the patients gave their written informed consent.
Interventions
DRUGCyclosporin A
COVID-19 pneumonia patients treated with oral CsA at a dose of 1-2 mg /kg / day divided into two doses, for 7 days, since entering to hospitalization.
Sponsors
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Consecutive patients with suspected or confirmed diagnosis of COVID-19 were assigned, in an unblinded and non-randomized fashion, to receive either steroids plus CsA (intervention group) or steroids only (standard of treatment in this hospital, control group), as per individual clinical judgment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed COVID 19 pneumonia by clinical, lung computed Tomography and RT-PCR nasopharyngeal swabs.
Exclusion criteria
* Influenza infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days to clinical improvement until hospital discharge or death. | 28 days. | Improvement of patients, defined by the following parameters: lower oxygen requirements (2 liters per minute, or less), absence of fever by three consecutive days, respiratory rate \<22, a decrease of 50% or more in the C reactive protein on admission, and length of hospital stay. |
Countries
Mexico
Contacts
Primary ContactJOSE LUIS J GALVEZ-ROMERO, MD
Outcome results
None listed